UNITED STATES
SECURITIES AND
EXCHANGE COMMISSION
WASHINGTON, D.C.
20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D) OF
THE SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): January 12, 2021
(Exact name of registrant as specified in its charter)
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(State or other jurisdiction of incorporation or organization)
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(Commission File Number)
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(I.R.S. Employer Identification No.)
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(Address of Principal Executive Offices) (Zip Code)
Registrant’s telephone number, including area code: (475 ) 230-2596
Not Applicable
(Former address if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any
of the following provisions (see General Instruction A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act
(17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act
(17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act
(17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act
(17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of
1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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Emerging growth company
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new
or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
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Item 2.02. Results of Operations and Financial Condition.
Please see the disclosure relating to the estimated revenue for Alexion Pharmaceuticals, Inc. (“Alexion” or the “Company”) for the fiscal year ended December
31, 2020 set forth under Item 7.01 “Regulation FD Disclosure” of this Current Report on Form 8-K, which is incorporated by reference into this Item 2.02.
Item 7.01 Regulation FD Disclosure.
Alexion will participate in the 39th Annual J.P. Morgan Healthcare Conference. Alexion Chief Financial Officer, Aradhana Sarin, will make a presentation on
Tuesday, January 12, 2021 at 7:30 a.m. ET using the slides furnished as Exhibit 99.1 to this Current Report on Form 8-K (the “Conference Presentation”) and incorporated herein by reference. Dr. Sarin’s presentation will be a virtual presentation.
The presentation will be webcast live and will be available at http://ir.alexion.com by clicking on an available link.
In addition, on January 12, 2020, Alexion issued a press release setting
forth certain highlights of the Company’s commercial, clinical and financial progress that are set forth in the Conference Presentation. This press release states that the Company expects to exceed the high end of the Company’s 2020 revenue
guidance of $5.9 billion to $5.95 billion that was previously provided by the Company in connection with its third quarter 2020 financial results. A copy of the press release is furnished as Exhibit 99.2 to this Form 8-K and incorporated herein by
reference.
The information in this Current Report on Form 8-K and the
attached Conference Presentation that we expect will be utilized at the 39th Annual J.P. Morgan Healthcare Conference, and the information set
forth therein, is being furnished pursuant to Item 2.02 and Item 7.01 of this Current Report on Form 8-K and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to
the liabilities of that Section. Nor shall such documents or information be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, regardless of any general incorporation language in the filing unless
specifically stated so therein.
Additional Information and Where to Find It
In connection with the proposed transaction, AstraZeneca PLC (“AstraZeneca”) intends to file with the SEC a registration statement on Form
F-4 that will include a proxy statement of Alexion and that also constitutes a prospectus of AstraZeneca. Each of Alexion and AstraZeneca may also file other relevant documents with the U.S. Securities and Exchange Commission (“SEC”) regarding the
proposed transaction. This document is not a substitute for the proxy statement/prospectus or registration statement or any other document that Alexion or AstraZeneca may file with the SEC. The definitive proxy statement/prospectus (if and when
available) will be mailed to stockholders of Alexion. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE REGISTRATION STATEMENT, PROXY STATEMENT/PROSPECTUS AND ANY OTHER RELEVANT DOCUMENTS THAT MAY BE FILED WITH THE SEC, AS WELL AS ANY
AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY IF AND WHEN THEY BECOME AVAILABLE BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. Investors and security holders will be able
to obtain free copies of the registration statement and proxy statement/prospectus (if and when available) and other documents containing important information about Alexion, AstraZeneca and the proposed transaction, once such documents are filed
with the SEC through the website maintained by the SEC at http://www.sec.gov. Copies of the documents filed with the SEC by Alexion will be available free of charge on Alexion’s website at http://www.alexion.com or by contacting Alexion’s Investor
Relations Department by email at InvestorRelations@alexion.com. Copies of the documents filed with the SEC by AstraZeneca will be available free of charge on AstraZeneca’s website at https://www.astrazeneca.com/investor-relations.html or by
contacting AstraZeneca’s Investor Relations department by email at global-mediateam@astrazeneca.com.
Participants in the Solicitation
Alexion, AstraZeneca, their respective directors and certain of their executive officers and other employees may be deemed to be
participants in the solicitation of proxies from Alexion’s stockholders in connection with the proposed transaction. Information regarding the persons who may, under the rules of the SEC, be deemed participants in the solicitation of Alexion
stockholders in connection with the proposed mergers, including a description of their direct or indirect interests, by security holdings or otherwise, will be set forth in the proxy statement/prospectus when it is filed with the SEC. Information
about Alexion’s directors and executive officers is available in Alexion’s proxy statement for its 2020 annual meeting of stockholders, which was filed with the SEC on March 26, 2020, Alexion’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2019, which was filed with the SEC on February 4, 2020, and other documents subsequently filed by Alexion with the SEC. Information about AstraZeneca’s directors and executive officers is available in AstraZeneca’s Form 20-F filed
with the SEC on March 3, 2020, and other documents subsequently filed by AstraZeneca with the SEC.
No Offer or Solicitation
This communication is not intended to and shall not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any
securities, or a solicitation of any vote or approval, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any
such jurisdiction. No offering of securities shall be made, except by means of a prospectus meeting the requirements of Section 10 of the U.S. Securities Act of 1933, as amended.
Forward Looking Statements
This communication contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended. You can generally identify forward-looking statements by the use of forward-looking terminology such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “explore,”
“evaluate,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” or “will,” or the negative thereof or other variations thereon or comparable terminology. These forward-looking statements are only predictions and
involve known and unknown risks and uncertainties, many of which are beyond Alexion’s and AstraZeneca’s control. Statements in this communication regarding Alexion, AstraZeneca and the combined company that are forward-looking, including projections
as to the expected revenue for Alexion for the fiscal year ended December 31, 2020, anticipated benefits of the proposed transaction, the impact of the proposed transaction on Alexion’s and AstraZeneca’s businesses and future financial and operating
results, the amount and timing of synergies from the proposed transaction, the terms and scope of the expected financing for the proposed transaction, the aggregate amount of indebtedness of the combined company following the closing of the proposed
transaction, are based on management’s estimates, assumptions and projections, and are subject to significant uncertainties and other factors, many of which are beyond Alexion’s and AstraZeneca’s control. These factors include, among other things,
market factors, completion of the audit of Alexion’s fiscal year 2020 financial results, competitive product development and approvals, pricing controls and pressures (including changes in rules and practices of managed care groups and institutional
and governmental purchasers), economic conditions such as interest rate and currency exchange rate fluctuations, judicial decisions, claims and concerns that may arise regarding the safety and efficacy of in-line products and product candidates,
changes to wholesaler inventory levels, variability in data provided by third parties, changes in, and interpretation of, governmental regulations and legislation affecting domestic or foreign operations, including tax obligations, changes to
business or tax planning strategies, difficulties and delays in product development, manufacturing or sales including any potential future recalls, patent positions and the ultimate outcome of any litigation matter. Additional information concerning
these risks, uncertainties and assumptions can be found in Alexion’s and AstraZeneca’s respective filings with the SEC, including the risk factors discussed in Alexion’s most recent Annual Report on Form 10-K, as updated by its Quarterly Reports on
Form 10-Q, in AstraZeneca’s most recent Annual Report on Form 20-F and in each company’s future filings with the SEC. Important risk factors could cause actual future results and other future events to differ materially from those currently
estimated by management, including, but not limited to, the risks that: a condition to the closing the proposed acquisition may not be satisfied; a regulatory approval that may be required for the proposed acquisition is delayed, is not obtained or
is obtained subject to conditions that are not anticipated; AstraZeneca is unable to achieve the synergies and value creation contemplated by the proposed acquisition; AstraZeneca is unable to promptly and effectively integrate Alexion’ s businesses;
management’s time and attention is diverted on transaction related issues; disruption from the transaction makes it more difficult to maintain business, contractual and operational relationships; the credit ratings of the combined company declines
following the proposed acquisition; legal proceedings are instituted against Alexion, AstraZeneca or the combined company; Alexion, AstraZeneca or the combined company is unable to retain key personnel; and the announcement or the consummation of the
proposed acquisition has a negative effect on the market price of the capital stock of Alexion or AstraZeneca or on Alexion’s or AstraZeneca’s operating results. No assurances can be given that any of the events anticipated by the forward-looking
statements will transpire or occur, or if any of them do occur, what impact they will have on the results of operations, financial condition or cash flows of Alexion or AstraZeneca. Should any risks and uncertainties develop into actual events,
these developments could have a material adverse effect on the proposed transaction and/or Alexion or AstraZeneca, AstraZeneca’s ability to successfully complete the proposed transaction and/or realize the expected benefits from the proposed
transaction. You are cautioned not to rely on Alexion’s and AstraZeneca’s forward-looking statements. These forward-looking statements are and will be based upon management’s then-current views and assumptions regarding future events and operating
performance, and are applicable only as of the dates of such statements. Neither Alexion nor AstraZeneca assumes any duty to update or revise forward-looking statements, whether as a result of new information, future events or otherwise, as of any
future date.
Item 9.01 Financial Statements and Exhibits.
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Exhibits
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Exhibit No.
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Description
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Corporate Presentation used at the 39th Annual J.P. Morgan Healthcare Conference on January 12, 2021
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Press Release dated January 12, 2021
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Cover Page Interactive Data File (embedded within the Inline XBRL document)
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Signature
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be
signed on its behalf by the undersigned hereunto duly authorized.
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Date: January 12, 2021
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ALEXION PHARMACEUTICALS, INC.
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By:
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/s/ Douglas Barry
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Name: Douglas Barry
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Title: Vice President, Corporate Law
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Exhibit 99.1
January 12, 2021 Chelsey living with NMOSD 39th AnnualJ.P. Morgan Healthcare Conference Aradhana
Sarin, M.D.Chief Financial Officer
Forward Looking Statements This presentation contains forward-looking statements, including
statements related to: the proposed acquisition by AstraZeneca and the anticipated timing of such acquisition; the benefits of the acquisition and the ability of the acquisition to deliver value to shareholders; the ability of AstraZeneca to
successfully integrate Alexion's operations, and the ability of AstraZeneca to implement its plans, forecasts and other expectations with respect to Alexion's business after the completion of the proposed acquisition and realize expected
synergies; Alexion’s anticipated financial results (including short-term guidance and long-range financial guidance), anticipated 2020 revenue, operating margin and non-GAAP EPS, revenue by 2025, our cumulative average growth rate through 2025,
and peak revenue from our pipeline beyond 2025 (and all of the assumptions, judgments and estimates related to such anticipated future results); ambition to quadruple the number of neurology patients in the US by 2025; ambition for 10 product
launches by 2023; anticipated future product launches (and the timing of those launches); plans to establish 7 blockbuster franchises and the targeted indications in each franchise; plans to make regulatory filings for approval of certain
products and product candidates, the expected timing of such filings as well as the expected timing of the receipt of certain regulatory approvals to market a product; our ambition to treat 7,500 neurology patients by 2025; our strategy and
ability to grow the ANDEXXA business both in indication and geography; ability to realize continued and sustainable growth in our aHUS franchise and metabolic business; the ability of our pipeline and existing products to provide long-term
sustainable growth for shareholders; Company’s plans for future clinical trials and studies, the timing for the commencement and conclusion of future clinical trials and the expected timing of the receipt of results of clinical trials and
studies; the anticipated number of patients that may be treated with the Company’s products both currently approved and in our pipeline; the Company’s goals for 2021 and near term events to support value creation for shareholders; the Company’s
strategy for long-term value creation (including the following: establishing ULTOMIRIS as the new standard of care in PNH, aHUS and Neurology, plans to launch our next generation C5 formulations, plans to expand our presence in Neurology, focus
expansion of ULTOMIRIS on direct-to-phase 3 rapid proof of concept trials, plans to further diversify our assets and establish novel platforms and the benefits of those plans); plans for additional formulations of ULTOMIRIS (high concentration
and subcutaneous) and the timing for regulatory approval and potential benefits of such formulations; Alexion’s ambitions for its portfolio of assets; the anticipated pricing of ULTOMIRIS in PNH and aHUS; ambitions to increase aHUS program; the
affected patient populations in the indications we are pursuing; plans to develop and launch ALXN1720; plans for our CSR program; the growth potential and plans for our FcRn program; and continued diversification of the pipeline.
Forward-looking statements are subject to factors that may cause Alexion's results and plans to differ materially from those forward-looking statements, including for example: the risk that the proposed acquisition of Alexion by Astra Zeneca
may not be completed and such failure could negatively affect our stock price and future business and financial results and if the Astra Zeneca merger agreement is terminated, we may be forced to pay a termination fee to Astra Zeneca; the
severity of the impact of the COVID-19 pandemic on Alexion’s business, including on commercial and clinical development programs; our dependence on sales from our C5 products (SOLIRIS and ULTOMIRIS); delays (expected or unexpected) in the time
it takes regulatory agencies to review and make determinations on applications for the marketing approval of our products; Alexion’s inability to timely submit (or failure to submit) future applications for regulatory approval for our products
and product candidates; payer, physician and patient acceptance of ULTOMIRIS as an alternative to SOLIRIS; appropriate pricing for ULTOMIRIS; future competition from biosimilars and novel products; inability to timely initiate (or failure to
initiate) and complete future clinical trials due to safety issues, IRB decisions, CMC-related issues, expense or unfavorable results from earlier trials (among other reasons); the number of patients that will use our products and product
candidates in the future; decisions of regulatory authorities regarding the adequacy of our research, marketing approval or material limitations on the marketing of our products; delays or failure of product candidates to obtain regulatory
approval; delays or the inability to launch product candidates due to regulatory restrictions, anticipated expense or other matters; interruptions or failures in the manufacture and supply of our products and our product candidates; failure to
satisfactorily address matters raised by the FDA and other regulatory agencies; results in early stage clinical trials may not be indicative of full results or results from later stage or larger clinical trials (or broader patient populations)
and do not ensure regulatory approval; the possibility that results of clinical trials are not predictive of safety and efficacy and potency of our products (or we fail to adequately operate or manage our clinical trials) which could cause us
to halt trials, delay or prevent us from making regulatory approval filings or result in denial of regulatory approval of our product candidates; unexpected delays in clinical trials; unexpected concerns that may arise from additional data or
analysis obtained during clinical trials; future product improvements may not be realized due to expense or feasibility or other factors; uncertainty of long-term success in developing, licensing or acquiring other product candidates or
additional indications for existing products; inability to complete acquisitions due to failure of regulatory approval or material changes in target or otherwise; inability to complete acquisitions and investments due to increased competition
for technology; the possibility that current rates of adoption of our products are not sustained (or anticipated adoption rates are not realized); internal development efforts do not result in commercialization of additional products; the
adequacy of our pharmacovigilance and drug safety reporting processes; failure to protect and enforce our data, intellectual property and proprietary rights and the risks and uncertainties relating to intellectual property claims, lawsuits and
challenges against us (including intellectual property lawsuits relating to products brought by third parties against Alexion); the risk that third party payors (including governmental agencies) will not reimburse or continue to reimburse for
the use of our products at acceptable rates or at all; failure to realize the benefits and potential of investments, collaborations, licenses and acquisitions; failure by regulatory authorities to approve transactions; the possibility that
expected tax benefits will not be realized or that tax liabilities exceed current expectations; assessment of impact of recent accounting pronouncements; potential declines in sovereign credit ratings or sovereign defaults in countries where we
sell our products; delay of collection or reduction in reimbursement due to adverse economic conditions or changes in government and private insurer regulations and approaches to reimbursement; uncertainties surrounding legal proceedings,
company investigations and government investigations; the risk that estimates regarding the number of patients with PNH, aHUS, gMG, NMOSD, HPP and LAL-D and other future indications we are pursuing are inaccurate; the risks of changing foreign
exchange rates; risks relating to the potential effects of the Company's restructuring; risks related to the acquisition of companies and co-development and collaboration efforts; and a variety of other risks set forth from time to time in
Alexion's filings with the SEC, including but not limited to the risks discussed in Alexion's Quarterly Report on Form 10-Q for the period ended September 30, 2020 and in our other filings with the SEC. Alexion disclaims any obligation to
update any of these forward-looking statements to reflect events or circumstances after the date hereof, except when a duty arises under law.In addition to financial information prepared in accordance with GAAP, this press release also contains
non-GAAP financial measures that Alexion believes, when considered together with the GAAP information, provide investors and management with supplemental information relating to performance, trends and prospects that promote a more complete
understanding of our operating results and financial position during different periods. Alexion also uses these non-GAAP financial measures to establish budgets, set operational goals and to evaluate the performance of the business. The
non-GAAP results, determined in accordance with our internal policies, exclude the impact of the following GAAP items (see reconciliation tables below for additional information): share-based compensation expense, fair value adjustment of
inventory acquired, amortization of purchased intangible assets, changes in fair value of contingent consideration, restructuring and related expenses, upfront payments related to licenses and other strategic agreements, acquired in-process
research and development, impairment of purchased intangible assets, gains and losses related to strategic equity investments, litigation charges, gain or loss on sale of a business or asset, gain or loss related to purchase options, contingent
milestone payments associated with acquisitions of legal entities accounted for as asset acquisitions, acquisition related costs and certain adjustments to income tax expense. These non-GAAP financial measures are not intended to be considered
in isolation or as a substitute for, or superior to, the financial measures prepared and presented in accordance with GAAP, and should be reviewed in conjunction with the relevant GAAP financial measures. Please refer to the attached
Reconciliations of GAAP to non-GAAP Financial Results and GAAP to non-GAAP Financial Guidance for explanations of the amounts adjusted to arrive at non-GAAP net income, non-GAAP and non-GAAP earnings per share amounts for the three and nine
month periods ended September 30, 2020 and 2019 and for the projected twelve months ending December 31, 2020.Amounts may not foot due to rounding.
ALEXION’S NEXT CHAPTER Our Next Chapter & Advances shared mission of following the science and
using innovative approaches to develop life-changing medicines for patientsStrengthens AstraZeneca’s presence in immunology by adding Alexion’s strong pipeline and unique complement technology platformsCombined company to have broad global
coverage across primary and specialty careAstraZeneca plans to create rare disease business unitCombined organization will be well positioned to accelerate innovation and deliver enhanced value for our shareholders, patients and rare disease
communities we serve
Standalone ALXN Targeting $9-10B in Global Revenues in 2025 1Ambition Baseline - 12/31/19 1,885
patients 2 2020 based guidance issued 10/29/20 32025 $9-10B target is at constant currencies (9/30/20 levels) 4 Illustrative, non risk-adjusted revenues, peak sales year varies by program Key Building Blocks To Achieving 2025 Revenue
Ambition Sustainable PNH and Growing aHUS & Metabolic Businesses Initial Revenue Contribution From 10 Launches By 2023 Expand Neurology U.S. Patient Volume 4x (to ~7,500 US Patients) 1 Grow ANDEXXA Utilization PATH FOR STRONG
GROWTH ~$6BGlobal Revenues2 $9-10BGlobal Revenues3 > 10% CAGR PNH (~30%) PNH (~15%) 2025 2020 2023 >$10B+in pipeline peak sales potential4 Beyond 2025 1 2 3 4
MISSION FOCUSED EXECUTION Compelling Portfolio For Patients
Today ULTOMIRIS®(ravulizumab-cwvz) SOLIRIS®(ECULIZUMAB) STRENSIQ®(ASFOTASE ALFA) KANUMA®(SEBELIPASE ALFA) ANDEXXA/ONDEXXYA®(ANDEXANET ALFA) 5 Transformative Products PNH(Paroxsysmal Nocturnal Hemoglobinuria) 7 Rare & Devastating
Conditions aHUS(Atypical Hemolytic Uremic Syndrome) gMG(Generalized Myesthenia Gravis) NMOSD(Neuromyelitis Optica Spectrum Disorder) HPP(Hypophosphatasia) LAL-D(Lysosomal Acid Lipase Deficiency) FxA Reversal(For Major Life-Threatening
Bleeds) Patient Centric Rare Disease Model Best In Class Data Analytics Rare Disease Focused Field Force Operational Excellence In Manufacturing & Supply Patient-centered Access Models Personalized High-Touch Patient Support
Services* *OneSource is a U.S. Patient Service Model RARE DISEASE TAILORED CAPABILITIES, FOCUS & GLOBAL SCALE
Ph3 to Initiate 1H ‘21 Transformed Our Development
Pipeline ULTOMIRIS ALXN1720 SOLIRIS LEAD and EXPAND IV (ALS) SC Weekly IV (gMG) IV (NMOSD) IV (HSCT-TMA) SC (DM)3 IV (CM-TMA) IV (Renal Basket) IV (COVID-19)2 IV (GBS) Japan Only SC
(gMG)3 ALXN1840 ALXN1830 CAEL-101 AG10 ALXN2040 ALXN2050 ANDEXXA CERDULATINIB DIVERSIFY IV (AL Amyloidosis)5 Oral (Wilson) SC FcRn (WAIHA)4 SC FcRn (gMG)4 Oral (PNH with EVH) Oral (PNH Monotherapy) Oral (ATTR-CM) Japan
Only6 Oral (Renal Basket) ANDEXXA-S (Urgent Surgery) Lymphoma (CTCL, PTCL, FL) Oral (Geographic Atrophy) Estimated TLR 2H ‘221 Estimated Filing 3Q ‘21 Estimated TLR 2H ‘211 Estimated TLR 2H ‘221 Ph3 Initiated 3Q ‘20 Estimated TLR 1H
‘211 Ph3 Initiated 4Q ‘20 Est. TLR 1H ‘211 Ph3 Initiated 4Q ‘20 Estimated TLR 2H ‘211 Ph3 Initiated 4Q ‘20 Ph2 to Initiate 1H ‘21 Ph3 to Initiate 1H ‘21 Ph2 Initiated 4Q ‘20 Estimated TLR 1H ‘211 Ph2 to Initiate 1H ‘21 Estimated TLR
1H ‘211 Ph2 to Initiate 2H ‘21 Est. TLR 1H ‘211 Hematology Metabolics Nephrology Ophthalmology Cardiology Neurology Acute Care PHASE 1 PHASE 2 PHASE 3 1TLR: Topline readout; 2Adults with COVID-19 who are hospitalized
with severe pneumonia or acute respiratory distress syndrome (ARDS); 31720 currently in HV Ph1 with topline readout estimated 1H ‘21 and subsequent DM and gMG trials to begin after that; 41830 Ph1 HV program to reinitiate for SC formulation
with WAIHA and gMG Ph2 programs to follow in 2021; 5Structured as option to acquire Caelum; 6Exclusive license to develop & commercialize in Japan MISSION FOCUSED EXECUTION ALXN1820 SC HV Study To Initiate 1Q ‘21 ALXN1850 SC HV
Study To Initiate 2Q ‘21 NEW NEW Other/TBD Ph2 to Initiate 2H ‘21 Ph2 to Initiate 2H ‘21 INITIATED INITIATED INITIATED INITIATED IND Filed 4Q ‘20 IND Filed 4Q ’20
MISSION FOCUSED EXECUTION With Potential for 7 Blockbuster Franchises LEAD AND
EXPAND Hematology Neurology Nephrology Metabolics Cardiology Ophthalmology Acute Care DIVERSIFY 1Japan Development Only Paroxysmal Nocturnal Hemoglobinuria (PNH) Warm Autoimmune Hemolytic Anemia(WAIHA) Hypophosphatasia
(HPP) Lysosomal Acid Lipase Deficiency(LAL-D) Wilson Disease Geographic Atrophy(GA) ALAmyloidosis Transthyretin Amyloid Cardiomyopathy1(ATTR-CM) Factor Xa Major Bleeds Factor Xa Reversal for Urgent Surgery Generalized Myasthenia
Gravis(gMG) Neuromyelitis Optica Spectrum Disorder(NMOSD) Amyotrophic Lateral Sclerosis(ALS) Dermatomyositis(DM) Guillain-Barre Syndrome1(GBS) Atypical Hemolytic Uremic Syndrome (aHUS) Renal Basket (LN, IgAN, PMN, C3G) Hematopoietic Stem
Cell Transplantation2(HSCT-TMA) Complement Mediated TMA(CM-TMA)
Strong Financial Execution 1A reconciliation of GAAP to non-GAAP financial results is
provided in the appendix and is available at www.alexion.com *2020E based on midpoint of 2020 financial guidance issued on October 29, 2020. The 2020 estimates (and related assumptions) set forth on this slide reflect estimates as of October
29, 2020 and the information on this slide has not been updated to reflect any events subsequent to October 29, 2020.. +19% CAGR +26% CAGR +1000 bps Double Digit Revenue Growth ($M) Consistent Non-GAAP EPS Growth1 Best-In-Class Non-GAAP
Operating Margins1 * MISSION FOCUSED EXECUTION +19% YoY Revenue Growth vs. 2019 highlights resilience of business despite Covid-19
Neurology is Key Growth Driver through 2025 PATH FOR STRONG GROWTH 1Ambition Baseline -
12/31/19 1,885 patients (4x growth ambition includes only gMG and NMOSD indications) AMBITION TO TREAT 4x U.S. NEUROLOGY PATIENTS US Neurology Patients (gMG & NMOSD) gMG Launch NMOSD Launch gMG Launch NMOSD Launch Estimated ULTOMIRIS
launch in gMG 2H 2022 ALXN1720 ~5-8KPatients ~20KPatients Majority of gMG AChR+ Patients Addressable Addressing Incremental Share of gMG Population With ULTOMIRIS Key to Achieving Ambition 60-80K Total US gMG
Patients 1 NEW ALXN1720 gMG Launch
PATH FOR STRONG GROWTH Maximizing ANDEXXA Potential Access Criteria FormularyBleeding
ProtocolEMR System Availability1DUR Conducted2 Awareness / Advocacy Clinical ChampionsReimbursement Pathway Awareness (incl. NTAP)Clinical & Economic Value Education Demand Generation Network Center Adoption & UtilizationReferral
Network Activation Underway Underway Underway Executing Against Re-Powered Launch Strategy Key Progress Acceleration of demand to pre-COVID levels in the US Progressing EU payer & access negotiations, launch
planning Executing against clinical and economic value education plans Integration and Re-Allocation of Commercial Efforts Expand Geographic Reach and Label of ANDEXXA Shift field teams to focus towards access and champion
mobilization Seek reimbursement in new markets and pursue development for broader label (edoxaban/enoxaparin & urgent surgery) Nearing Completion Underway Focus On Optimizing New and Existing Top Tier Accounts 1EMR: Electronic
Medical Record; 2DUR: Drug Use Review Filed sBLA to expand US label to include enoxaparin and edoxaban
PATH FOR STRONG GROWTH Confidence in Sustainability of C5 Franchise ALXN1720 First
Generation C5 Second Generation C5 Third Generation C5 Expanding to Rare >50K Potential Addressable Patients Ultra-Rare Focus<6K Patients Continued Expansion in Rare>100K Potential Addressable Patients IMPROVING PROFILE FOR
PATIENTS THROUGH THREE GENERATIONS of C5 INHIBITION Compelling ULTOMIRIS Profile Majority of C5 market will convert to ULTOMIRIS vs. SOLIRISPoint estimates in favor of ULTOMIRIS on all 11 endpoints across two large Ph3 studiesProven long-term
safety recordDosing convenience with only 6-7 (Q8W) 45-minute infusions per year Expected dosing optionality with once-weekly SC self-administration in PNH/aHUS; exploring SC optionality in neurology as clinical data would likely be
requiredConvenient product profile offered at a discount annually relative to SOLIRISAnnual treatment cost per patient vs. SOLIRIS is 10% lower in PNH / ~30% lower in aHUS and future Neurology indications in maintenance phaseLayers of
intellectual property protection across indications & geographies Bi-Specific Mini-Body Long-Acting, Small Volume Subcutaneous Dosing Potential for auto-injector or pre-filled syringe On Track for Ph1 Healthy Volunteer Data 1H 2021
PATH FOR STRONG GROWTH On Track For 10 Launches By 2023 1. Commercial estimate 2. Prevalence of
ALS-United States, 2015 MMWR Morb Mortal Wkly Rep. 2018 Nov 23; 67(46): 1285-1289 3. Jodele S, Davies SM, Lane A, et al. Diagnostic and risk criteria for HSCT-associated thrombotic microangiopathy: a study in children and young adults. Blood.
2014;124(4):645–653. 4. Aligned with our Phase 3 PREVENT criteria 5.Alexion estimated market opportunity incremental to existing aHUS market 6. Saito T, Arimura K, No M. Result report of the National Epidemiology Survey secondary questionnaire
survey on Guillain-Barré syndrome, Ministry of Health, Labour and Welfare specific disease, Immunologic neurological disease investigation sub-group Year 2000 Research Report, 2000;83-84. 7. Quock, T. P., et al. Epidemiology of AL amyloidosis:
a real-world study using US claims data. Blood Adv. 2018; 2(10):1046-1053 8. Eidos Therapeutics 9. Poujois, A., et al. Characteristics and prevalence of Wilson's disease: A 2013 observational population-based study in France. Clin Res Hepatol
Gastroenterol. 2018 Feb;42(1):57-6 10. Risitano AM, et al. Blood.2009;113(17):4094-4100 LEAD AND EXPAND IN COMPLEMENT GBSJapan Only gMG ALS NMOSD HSCT-TMA CM-TMA AL Amyloidosis Wilson Disease ATTR-CMJapan Only PNH with
EVH ALXN1840 ALXN2040 PNH / aHUS WEEKLY SC DIVERSIFY INTO NEW GROWTH AREAS Best in Class C5 InhibitorULTOMIRIS Ph3 Trial>80% Enrolled Best in ClassC5 InhibitorULTOMIRIS First in Class C5 InhibitorULTOMIRIS U.S.
Diagnosed Population2 U.S. Target Population4 U.S. Diagnosed Population3 Ph3 TrialEnrollmentUnderway First and OnlyC5 InhibitorULTOMIRIS Ph3 TrialTo Initiate 1H ‘21 ~2K Addt U.S. Opportunity5 <2K JP Diagnosed Population6 First and
Only C5 InhibitorSOLIRIS Best in Class C5 InhibitorULTOMIRIS Ph3 TrialTo Initiate 1H ‘21 ~10K U.S. Diagnosed Population7 <6K JP Diagnosed Population8 ~5K U.S. Diagnosed Population9 First and OnlyTargeted Therapy Ph3 TrialInitiated3Q
‘20 First and OnlySmall Molecule Ph3 TrialEnrollment Underway Potential Superiority vs Standard of Care Ph3 TrialOn-Going; Data 1H ‘21 Address PatientsSuffering from EVH Ph3 TrialEnrollmentUnderway Ph3 TrialTo File 3Q ‘21 First in
Class SC InfusionC5 Inhibitor <6K EachU.S. Ultra-Rare Population U.S. Target Population1 <10% U.S. PNH Population10 ~20K ~15K ~5K ~4.5K Ph3 TrialEnrollment Complete NEW NEW Ph3 Trial>50%
Enrolled NEW NEW NEW NEW
MOMENTUM CONTINUES IN 2021 Advancing Shared Mission to Deliver Life-Changing
Medicines PROPOSED ASTRA ZENECA ACQUISITION OF ALEXION EXPECTED TO CLOSE IN 3Q 2021 LEAD IN COMPLEMENT EXPAND IN COMPLEMENT DIVERSIFY Into New Growth Areas 2020 2021 Establish ULTOMIRIS as standard of careContinue to innovate for
patientsDevelop and launch next generation C5 >70% PNH ULTOMIRIS converted in US, DE, JPULTOMIRIS 100mg/mL approval (US & EU)ALXN1720 Ph1 continued to enroll >70% aHUS ULTOMIRIS converted in US (2H)ULTOMIRIS once-weekly SC filing
(3Q)ALXN1720 Ph1 top line data (1H) Expand presence in Neurology Focus new ULTOMIRIS expansion on direct to Ph3 and rapid proof of concept studies Expand rare disease focus with novel assetsGrow acute care presence with ANDEXXA 4x
US Neuro ambition set: >700 new patientsgMG Ph3 ULTOMIRIS enrollment completeNMOSD Ph3 ULTOMIRIS enrollment >80%ALS Ph3 ULTOMIRIS trial initiated; >50% enrolled gMG Ph3 ULTOMIRIS top line data (2H)gMG ULTOMIRIS filing (2H)NMOSD &
ALS Ph3 ULTOMIRIS full enrollment (2H)ULTOMIRIS Nephrology1 enrollment progress (FY) Ph3 ALXN1840 fully enrolledPh3 CAEL-101 trial initiatedPTLA acquisition closed Ph3 ALXN1840 top line data (1H)ALXN1840 filing in Wilson Disease (2H)Ph2
ALXN2040 Geographic Atrophy initiation (2H)ANDEXXA growth (FY) 1 Refers to ULTOMIRIS HSCT-TMA and CM-TMA Ph3 and Renal Basket Ph2 Trials
Our Mission: Transform the lives of people affected by rare diseases and devastating conditions by
continuously innovating and creating meaningful value in all we do Jesse living with gMG Thank You Committed to Corporate Social Responsibility Diversity, Inclusion, & Belonging At AlexionAt Alexion, Diversity is having a seat at the
table. Inclusion is having a voice. Belonging is having that voice be heard. Our Commitment: The MassBio CEO Pledge for a More Equitable and Inclusive Life Sciences Industry Serve Communities And Sustain Our PlanetTransform Patient
LivesAdvance Our People And Our CompanyRedefine What It Means To Live With A Rare Disease Ethics & Compliance: Our Foundation
Investor dayAPPENDIX 0 | Jesse living with gMG
Rare Disease By The Numbers RARE DISEASES AFFECT APPENDIX 30MILLION OF ALL
RAREDISEASES 5% PEOPLE IN THE UNITED STATES ARE AFFECTED BY RARE DISEASETHAT IS APPROXIMATELY APPROVEDTREATMENTS ARE AVAILABLE FOR ONLY Source: GAO Orphan Drugs November 2016; Global Genes 1 IN 10 7,000RARE DISEASES ARE KNOWN TO
EXIST TODAY 50% OF RARE DISEASE PATIENTS IN THE U.S. ARE CHILDREN BY DEFINITION A RARE DISEASE AFFECTS PATIENTS IN THE U.S. <200,000 Donnan living with aHUS
Albie living with LAL-D Sumaira living with NMOSD Our Mission: Transform the lives of people affected
by rare diseases and devastating conditions by continuously innovating and creating meaningful value in all we do Jesse living with gMG Justice living with aHUS Bunny living with PNH Aira living with HPP
APPENDIX LEAD AND EXPAND IN COMPLEMENT DIVERSIFY INTO NEW GROWTH AREAS Secure and grow our base
business Drive new growth opportunities outside C5 LEADEstablish ULTOMIRIS as the new standard of carePNHaHUSNeurology in 2022/2023Develop and launch next-generation innovative C5 formulations EXPANDExpand presence in Neurology Focus new
ULTOMIRIS expansion opportunities on direct-to-Phase 3, rapid Proof of Concept DIVERSIFYExecute novel asset development to expand rare disease focusGrow acute care presence with ANDEXXA Our Value Creation Strategy
APPENDIX Q3 2020 YTD Revenue Composition * Through 9/30/2020, as reported
10/29/2020 Geography Product US, DE, and JP >70% of Global Revenues C5 Franchise ~85% of Global Revenues
APPENDIX ULTOMIRIS Conversion Progress Dec 2018U.S. PNH ULTOMIRIS Approval Oct 2019U.S. aHUS
ULTOMIRISApproval Jun 2020EU aHUS ULTOMIRISApproval 3Q 2020 Sep 2020JP aHUS ULTOMIRISApproval Jun 2019JP PNH ULTOMIRIS Approval Jul 2019EU PNH ULTOMIRIS Approval aHUS ULTOMIRIS Conversion On Track T0 70% Ambition1 PNH ULTOMIRIS
70% Conversion In Top Three Markets Achieved 1aHUS ambition of 70% of total patients on ULTOMIRIS within 2 years of launch; 2Pending regulatory approval following completion of Phase 3 studies 2H 2022Estimated gMG ULTOMIRISApproval2 1H
2023Estimated NMOSD ULTOMIRISApproval2 Ambition for best-in-class conversion across all indications
APPENDIX ULTOMIRIS Conversion Dynamic: Two Key Considerations Conversion Loading Dose
Dynamic Quarter-on-quarter (QoQ) Variability ULTOMIRIS vs. SOLIRIS U.S. Annual Cost Per Patient Maintenance Dosing Year 1: Loading dose + Maintenance Dosing SOLIRIS indication-specific dosing: aHUS, gMG, NMOSD labeled dose higher than
PNHDrives indication-specific pricing differences when comparing SOLIRIS vs. ULTOMIRIS pricingULTOMIRIS weight-based dosing ULTOMIRIS every 8 week infusion schedule drives variability in quarterly patient treatment costs Expect quarterly
variability to be negligible on year-over-year (YoY) revenue comparisons Note: pricing discounts are approximations, not exact Infusion Timing Drives QoQ Variability Patient Sample 1: Loading dose + 2 Maintenance Infusions Patient Sample
2: Loading dose + 1 Maintenance Infusion Loading dose Maintenance Infusion
Ample Opportunity to Expand C5 Platform
Reach APPENDIX 2023 gMG ALS NMOSD HSCT-TMA CM-TMA Best in Class C5 InhibitorULTOMIRIS Ph3 Trial>50% Enrolled Best in ClassC5 InhibitorULTOMIRIS Ph3 TrialEnrollment On-Going First in Class C5
InhibitorULTOMIRIS U.S. Diagnosed Population2 U.S. Target Population4 U.S. Diagnosed Population3 Ph3 TrialInitiated4Q ‘20 First and OnlyC5 InhibitorULTOMIRIS Ph3 TrialTo Initiate 1H ‘21 ~2K Addt U.S. Opportunity5 Best in Class C5
InhibitorULTOMIRIS U.S. Target Population1 ~20K ~15K ~5K ~4.5K Ph3 Trial>90% Enrolled ULTOMIRIS expansion a key component of ambition for 10 launches by 2023 Pursing role of terminal complement inhibition in IgAN and LNUS
diagnosed prevalence of ~150K patientsPh2 proof of concept trial initiated 4Q 2020 Renal Basket Evolving gMG portfolio strategy to target the majority of AChR+ gMG patientsUS diagnosed prevalence of 60-80K patientsTo pursue following Ph1
data in 1H 2021 gMG Expanding footprint in neuromuscular and rare autoimmune diseases US diagnosed prevalence of classic DM ~40KTo pursue following Ph1 data in 1H 2021 DM With even broader rare diseases populations in scope for development
beyond ALXN1720 ULTOMIRIS
Diversifying Beyond C5 APPENDIX 2023 Opportunities to diversify broaden ambition for
10 launches by 2023 Once-weekly SC FcRn supports gMG portfolio strategyPh2 trial to initiate 2H 2021 gMG Systemic, oral approach to slow disease progressionPh2 trial to initiate 2H 2021 with ALXN2040 GA With innovative platforms and
novel assets continuing to diversify portfolio long-term Factor D ALXN1830 AL Amyloidosis Wilson Disease ATTR-CMJapan Only PNH with EVH ~10K U.S. Diagnosed Population7 <6K JP Diagnosed Population8 ~5K U.S. Diagnosed
Population9 First and OnlyTargeted Therapy Ph3 TrialInitiated3Q ‘20 Best in ClassSmall Molecule Ph3 TrialTo Initiate 4Q ‘20 Potential Superiority vs Standard of Care Ph3 TrialOn-Going; Data 1H ‘21 Address PatientsSuffering from EVH Ph3
TrialTo Initiate 4Q ‘20 <10% U.S. PNH Population10 Once-weekly SC FcRn expands hematology presencePh2 trial to initiate 2H 2021 WAIHA Exploring fD in LN, IgAN, PMN, and C3GPh2 trial to initiate 1H 2021 with ALXN2050 Renal
Basket Launch “reboot” and label expansion efforts underwayPh2 Urgent Surgery trial to begin 2H2021 ANDEXXA Novel anti-properdin mini-bodyFirst-in-human studies to begin 1H 2021 ALXN1820 Next-gen asfotase alfa
(STRENSIQ)First-in-human studies to begin 1H2021 ALXN1850
APPENDIX Vast Opportunity In FcRn Landscape ALXN1830 Value Proposition SC single doses suggest
meaningful IgG-lowering potential prior to study pause due to COVID-19 Preliminary PK/PD modeling suggests 1500mg weekly SC may have the potential to provide >70% IgG loweringDosing would be compatible with convenient SC delivery via
on-body device Rapid onset of action and sustained IgG lowering after a single doseExcellent PK/PD profile for indications of interest with >70% IgG lowering expected and high specificity to IgGReduces IgG immunocomplexes levelsSuperior
dosing profile with once weekly subcutaneous administrationFavorable safety profile to date: No effect on albumin, eliminating concerns of hypoalbuminemiaNo headache seen thus far in SC HVPotential for combination therapy with Alexion’s
complement mini-bodies including ALXN1720 and ALXN1820 Positive Early Signal from SC Phase 1 Study HV Ph1 WAIHA 1H 2021 ALXN1830 SC ALXN1830 SC 2H 2021 Ph2 SAD/MAD gMG ALXN1830 SC Ph2 FcRn Has Potential to Treat Hundreds of
Thousands of Patients with IgG Mediated Diseases Including gMG, WAIHA, CIDP etc
APPENDIX ULTOMIRISNew IndicationsALS (2023)HSCT-TMA (2023)CM-TMA (2023) $500M to
$1B $1.0B+Combined $500M to $2.0B+ ALXN1840Wilson Disease (2022) CAEL-1011AL Amyloidosis (2023)AG10ATTR-CM (2023) Japan Only ALXN1830WAIHA (2023+)gMG (2023+) Factor D2PNH (2023+)GA (2023+)Renal (2023+) LEAD and EXPAND in complement
DIVERSIFY into new growth areas (sourced through BD) $1.0B+ ANDEXXAFactor Xa (2020)Urgent Surgery (2023+) SOLIRISGBS (2023) Japan Only ALXN1720DM (2023+)gMG (2023+) $1.0B+ <$100M $2 to $3B $1 to $4B Illustrative
only; timing shown represents launch year; based on non-adjusted peak revenue estimates for incremental market opportunity; 1Structured as an option to acquire Caelum; 2Factor D represents both ALXN2040 and ALXN2050 Development-Stage Pipeline
with >$10B+ in Potential Peak Sales 7 BlockbusterFranchises
APPENDIX Near-Term Events Support Alexion’s Value Creation
Strategy LEAD EXPAND DIVERSIFY US IPR Settlement (SOLIRIS Patents) ULTOMIRIS PNH Subcutaneous Ph3 Top Line Results (PK) 2Q 2020 2Q 2020 ULTOMIRIS aHUS EMA Approval by EC Mid 2020 ULTOMIRIS 100mg/ml Formulation
FDA & EMA Approval 2H 2020 4Q 2020 ULTOMIRIS Ph2 Renal Basket Trial Initiation ALXN2040 C3G Ph2 Top Line Results Mid 2020 Portola Acquisition Close 3Q 2020 CAEL-101 Ph3 Trial Initiation 2H 2020 ALXN2060 (AG10) Japan Ph3
Initiation 4Q 2020 ALXN1840 Wilson Ph3 Top Line Results 1H 2021 4Q 2020 ULTOMIRIS HSCT-TMA Ph3 Trial Initiation 1H 2021 ULTOMIRIS COVID-19 Ph3 Interim Results ULTOMIRIS Subcutaneous PNH/aHUS Launch Mid 2022 2H 2022 ULTOMIRIS ALS Ph3
Top Line Results 2H 2021 ULTOMIRIS gMG Ph3 Top Line Results 2H 2022 ULTOMIRIS NMOSD Ph3 Top Line Results ALXN2050 PNH Ph2 Top Line Results 2H 2021 ALXN1840 Wilson Launch 2H 2022 ALXN2040 GA Ph2 Initiation 2H 2021 ALXN2060 (AG10)
Japan Ph3 Top Line Results 2H 2022 ALXN1850 IND Filing 2H 2020 ALXN1820 IND Filing 2H 2020 2H 2022 ULTOMIRIS gMG FDA Approval
APPENDIX CSR and ESG at Alexion COMMITTED TO CONTINUING ELEVATION OF CSR REPORTING IN
2021 (Alexion’s Inaugural CSR Report Published in 2020) Download Alexion’s Inaugural 2019 CSR Report at csr.alexion.com “At Alexion, we work to change lives for the better – ours, people living with rare diseases and the communities we
serve – and our commitment to being a responsible corporate citizen helps make it possible.”CEO LUDWIG HANTSON Recognition 1st Decile Rank(Pharmaceuticals & Biotech) Double Digit Growth #1 ESG Risk Rating(Biotech) Ranked161 out of 400
(Top 40%)
APPENDIX Commercial Portfolio Patent & Orphan Exclusivity Product Region Patent
Exclusivity Orphan Exclusivity Data Exclusivity ULTOMIRIS US 2035 PNH 2025aHUS (SC only; filing 3Q 2021) 2030 EU 2035 N/A 2029 Japan 2035 PNH 2029 2029 SOLIRIS US 20271 gMG 2024NMO 2026 2019 EU 20202 aHUS 2023gMG
2027NMO 2029 2018 Japan 2027 gMG 2027NMO
2029 2020 STRENSIQ US 2029 2022 2027 EU 2030 2027 2025 Japan 2028 2025 2025 KANUMA US 2031 2022 2027 EU 2031 2027 2025 Japan 2031 2026 2026 ANDEXXA/ONDEXXYA US 2030 2025 2030 EU 2033 N/A 2029 Japan 2028 N/A 1
Alexion licensed Amgen to commercialize biosimilar eculizumab effective March 1, 2025 (or earlier in certain circumstances). See IPR settlement agreement dated May 28, 20202 The following patents are under appeal which would extend patent to
2027: '834 Method of Use Patent was approved, then subsequently revoked in January 2019. Patent is in effect as Alexion appeals. ‘888 and ‘029 patent applications were rejected, and Alexion has begun the process to appeal these decisions. These
patents are not in effect during appeal
APPENDIX: LATE STAGE PIPELINE TRACKER Identifier (Other) Name
(INN) MOA ROA Indication Phase Study Start Anticipated Study End SOLIRIS (eculizumab) Anti-C5 Q2W IV Guillain Barre Syndrome Ph3 Initiating 1H ‘21 Not yet disclosed ALXN1210 ULTOMIRIS (ravulizumab) Anti-C5 Q1W SC Paroxsymal
Nocturnal Hemoglobinuria (PNH)Atypical Hemolytic Uremic Syndrome (aHUS) Ph3 Initiated 1Q ‘19 TLR 2Q ‘20Filing 3Q ’21 Q8W IV Generalized Myasthenia Gravis (gMG) Ph3 Initiated 1Q ‘19 TLR 2H ‘21 Neuromyelitis Optica Spectrum
Disorder (NMOSD) Ph3 Initiated 4Q ‘19 TLR 2H ‘22 Amyotrophic Lateral Sclerosis (ALS) Ph3 Initiated 1Q ‘20 TLR 2H ‘22 Hematopoetic Stem Cell Transplant Thrombotic Microangiopathy (HSCT-TMA) Ph3 Initiated 4Q ’20 Not yet
disclosed Complement Mediated Thrombotic Microangiopathy (CM-TMA) Ph3 Initiating 1H ’21 Not yet disclosed Adults with COVID-19 who are hospitalized with severe pneumonia or ARDS Ph3 Initiated 2Q ‘20 TLR 1H
‘21 Renal Basket Study Ph2 Initiated 4Q ’20 Not yet disclosed ALXN1720 N/A Anti-C5 Bi-Specific SC Generalized Myasthenia Gravis (gMG)1 Ph1 HV Reinitiated 3Q ’20 TLR 1H ‘21 Dermatomyositis
(DM)1 ALXN1840(WTX-101) (Bis-choline tetrathiomolybdate) Copper chelator Oral Wilson Disease Ph3 Initiated 1Q ’18 TLR 1H ‘21 ALXN1830(SYNT-001) N/A Anti-FcRn SC Warm Autoimmune Hemolytic Anemia (WAIHA)2 Ph1 HV Reinitiating
1H ‘21 TLR 1H ‘21 Generalized Myasthenia Gravis (gMG)2 CAEL-101 N/A AL/AL fibril reactive antibody IV Amyloid Light-Chain (AL) Amyloidosis Ph3 Initiated 3Q ’20 TLR 2H ‘22 ALXN2060 (AG10) (acoramidis) TTR tetramers
stabilizer (small molecule) Oral Transthyretin Amyloid Cardiomyopathy (ATTR-CM) Ph3 Initiated 4Q ’20 TLR 2H ‘22 ALXN2040(ACH-4471) (danicopan) Factor D inhibitor (small molecule) TID Oral PNH with Extravascular Hemolysis (PNH w/
EVH) Ph3 Initiated 4Q ’20 TLR 2H ‘22 TBD Geographic Atrophy Ph2 Initiating 2H ’21 Not yet disclosed ALXN2050(ACH-5228) (vermicopan) Factor D inhibitor (small molecule) BID Oral Paroxsymal Nocturnal Hemoglobinuria
(PNH) Ph2 Initiated 4Q ’19 TLR 2H ‘21 Renal Basket Study Ph2 Initiating 1H ’21 Not yet disclosed ALXN2070 ANDEXXA (andexanet alfa) Factor Xa Reversal IV Urgent Surgery Ph2 Initiating 1H ’21 Not yet
disclosed ALXN2075 (cerdulatinib) SYK/JAK kinase inhibitor Oral Lymphoma (CTCL, PTCL, FL) Ph2 PTLA Acquisition TLR 1H ‘21 ALXN1820 N/A Anti-Properdin Mini-Body SC Not yet disclosed Ph1 Initiating 1Q ‘21 Not yet
disclosed ALXN1850 N/A Next generation alfotase alfa SC Not yet disclosed Ph1 Initiating 2Q ‘21 Not yet disclosed 11720 currently in HV Ph1 with topline readout estimated 1H ‘21 and subsequent DM and gMG trials to begin after that;
21830 Ph1 HV program to reinitiate for SC formulation with WAIHA and gMG Ph2 programs to follow in 2021
APPENDIX Alexion Current Indications Indication Description Links PNH Paroxysmal Nocturnal
Hemoglobinuria Chronic, debilitating, and potentially life-threatening ultra-rare blood disorder, with an average age of onset in the early 30s more info aHUS atypical Hemolytic Uremic Syndrome Ultra-rare, genetic, chronic, potentially
life-threatening disease. Chronic uncontrolled complement activation results in thrombotic microangiopathy (TMA) more info gMG Generalized Myasthenia Gravis Debilitating, chronic, and progressive autoimmune neuromuscular disease. more
info NMOSD Neuromyelitis Optica Spectrum Disorder Rare, devastating, complement-mediated disorder of the central nervous system characterized by relapses where each individual attack results in cumulative disability including blindness and
paralysis, and sometimes premature death (primarily affects women) more info HPP Hypophosphatemia Inherited, progressive, ultra-rare metabolic disease in which patients experience devastating effects on multiple systems of the body, and
face debilitating or life-threatening complications more info LAL-D Liposomal Acid Lipase Deficiency Genetic, chronic, and progressive ultra-rare metabolic disease in which infants, children, and adults experience continuous, uncontrolled
accumulation of cholesteryl esters (CEs) and triglycerides (TGs) that may lead to multi-organ damage and premature death more info ANDEXXA Coagulation factor Xa reversal (recombinant) Reversal agent for life-threatening bleeds induced by
factor Xa inhibitors more info
APPENDIX Alexion Pipeline Indications - I Indication Description Links WD Wilson
Disease Rare, chronic, genetic, and potentially life-threatening liver disorder of impaired copper transport. The disorder is characterized by build-up of intra-cellular hepatic copper. Untreated, Wilson disease leads to various combinations
and severity of hepatic, neurologic, and psychiatric symptoms, and can be fatal. ALA AL (Light-chain) Amyloidosis A protein misfolding disorder in which B-cells produce incomplete and light chain antibodies which clump in certain
organs / tissues (including heart, lungs, kidneys, nervous system, and liver, eventually causing organ damage and death. more info PNH-EVH Paroxysmal Nocturnal Hemoglobinuria with Extravascular Hemolysis Chronic, debilitating, and
potentially life-threatening ultra-rare blood disorder, with an average age of onset in the early 30s. EVH occurs when C3 opsonization of red blood cells causes macrophages to destroy those cells in tissue. DM Dermatomyositis Progressive
autoimmune condition that causes skin changes and muscle weakness. Symptoms can include a red skin rash around the eyelids, red bumps around the joints, and muscle weakness in the arms and legs. Dermatomyositis is most common in adults between
ages 40 and 60, or in children between ages 5 and 15. more info HSCT-TMA Hematopoetic Stem Cell Transplant Thrombotic Micro-Angiopathy A significant and often lethal complication of HSCT. The condition is a systemic, multifactorial disorder
caused by endothelial cell damage induced by conditioning regimens, immunosuppressant therapies, infection, graft versus host disease (GVHD), and other factors associated with HSCT. HSCT-TMA prognosis is poor, with overall mortality reported as
high as ~80-90%.
APPENDIX Alexion Pipeline Indications - II Indication Description Links
CM-TMA Complement-Mediated Thrombotic Micro-Angiopathy Caused by abnormalities of regulation of the alternative pathway of complement activation. The indication describes a group of severe and chronic ultra-rare diseases that can cause
progressive injury to vital organs— via damage to the walls of blood vessels and blood clots—potentially leading to organ failure and premature death. CM-TMA affects both adults and children and represents the population of patients with aHUS
with or without triggers. COVID-19 Severe Acute Respiratory Distress Syndrome in COVID-19 patients Patients with severe illness include those who are hospitalized with severe pneumonia or acute respiratory distress syndrome. Evidence
suggests that acute lung injury associated with COVID-19 may be mediated in part by complement pathway whereby elevated C5 ultimately leads to severe pneumonia, blood clots and multi-organ dysfunction in many advanced COVID patients.
WAIHA Warm Auto-Immune Hemolytic Anemia Rare autoimmune disorder caused by pathogenic Immunoglobulin G (IgG) antibodies that react with and cause the premature destruction of red blood cells at normal body temperature. The disease is
often characterized by profound, and potentially life-threatening anemia and other acute complications. ATTR-CM Transthyretin Amyloidosis (ATTR) with Cardiomyopathy (ATTR-CM) A progressive, fatal disease caused by the accumulation of
misfolded tetrameric transthyretin (TTR) amyloid in the heart. Caused by the destabilization of TTR due to inherited mutations or aging, symptoms usually manifest later in life (age 50+), with median survival of three to five years from
diagnosis.
APPENDIX Alexion Pipeline Indications - III Indication Description Links LN Lupus
Nephritis An inflammatory renal disease that is a severe complication of systemic lupus erythematosus (SLE), in which deposits of immune complexes (e.g., IgG and complement) accumulate in the kidney and lead to injury. Approximately 30% SLE
patients develop LN, and up to 30% of patients are refractory to treatment and progress to end stage renal disease requiring dialysis/transplant within 15 years . There are no FDA approved therapies for LN. PMN Primary Membranous
Nephropathy Rare autoimmune disease characterized by autoantibodies to the podocyte membrane antigens PLA2R (~85%) and THSD7A (~5%) that causes nephrotic syndrome and chronic kidney disease. Approximately 30% of patients will progress to end
stage renal disease within 10 years of diagnosis. IgAN IgA Nephropathy (IgAN) A heterogenous disease in terms of clinical manifestations and progression and is the most common cause of primary glomerulonephritis. In IgAN, locally deposited
immune complexes lead to activation of the complement cascade & downstream endothelial organ damage. The Lectin and Alternative Pathways are believed to be the main driver of disease progression, which includes end stage renal disease and
need for dialysis or transplant. C3G Complement 3 Glomerulopathy Ultra-rare, heterogenous renal disease characterized by uncontrolled continued activation of fluid and/or solid phase alternative pathway causing C3 deposition and
inflammation, leading to kidney damage . ALS Amyotrophic lateral sclerosis A rare neurological disorder of progressive deterioration of nerve cells (motor neurons) in the brain and the spinal cord that control muscles throughout the body.
Loss of motor neurons and muscle strength leads to loss of independence, paralysis and death, typically due to respiratory insufficiency.
APPENDIX
APPENDIX
Exhibit 99.2
Alexion
Highlights Commercial, Clinical and Financial Progress at the 39th Annual J.P. Morgan Healthcare Conference
- Continued advancement of pipeline, including initiation of three Phase 3 development programs and two novel IND filings in Q4 2020 -
- Expects to exceed the high end of 2020 revenue guidance, given at Q3 2020 results, of $5.9-$5.95 billion -
- Recently announced acquisition agreement will enhance AstraZeneca’s presence in immunology and provides opportunity to expand on
Alexion’s innovative complement-technology platforms -
BOSTON – JANUARY 12, 2021 - Alexion
Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced recent commercial, clinical and financial progress and upcoming 2021 milestones, which will be detailed today in the company’s presentation at the 39th Annual J.P. Morgan Healthcare
Conference.
“Over the course of past year, Alexion has continued to execute on its value-creation strategy and delivered on the potential of its robust portfolio and
clinical pipeline, giving us great momentum as we enter 2021. I am very proud of the hard work of all our teams who continue to be so dedicated to serving patients across the globe,” said Ludwig Hantson, Ph.D., Chief Executive Officer at Alexion.
“For almost 30 years, Alexion has been committed to transforming the lives of those impacted by rare diseases and devastating conditions, and the company remains focused on advancing its innovative therapies and pipeline to drive value for patients
and shareholders once we are part of AstraZeneca.”
Robust Portfolio Positions Alexion for Growth
Alexion continues to expand into additional therapeutic areas, with a pipeline of more than 20 development programs across seven rare disease franchises.
The company has the ambition to deliver double-digit topline growth through 2025, targeting $9 to $10 billion in global revenue. This revenue target is expected to be driven by the continued growth of Alexion’s neurology franchise; expansion of
ANDEXXA/ONDEXXYA® [coagulation factor Xa (recombinant), inactivated-zhzo] into new indications and geographies; sustainable paroxysmal nocturnal hemoglobinuria (PNH) and growing atypical hemolytic uremic syndrome (aHUS) and metabolics
businesses; and initial revenue contributions from 10 potential new launches by 2023.
Amidst COVID-19 pressures throughout 2020, Alexion added more than 700 U.S. neurology patients over the course of the year, and now serves nearly 2,600
patients in the U.S. The company remains on track to reach its stated long-term ambition to treat roughly 7,500 people with generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD) in the United States by year end 2025.
Continued Pipeline Progress
Alexion remains confident in the sustainability and growth potential of its innovative pipeline. Over the course of 2020, the company has built upon, and
expanded its expertise in terminal complement inhibition and other areas. Select pipeline updates, since third quarter results were reported in October 2020, regarding promising individual programs and broader platform opportunities include:
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Completion of enrollment in the Phase 3 trial of ULTOMIRIS in gMG, with top-line data expected in the second half of 2021.
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Continued progress in advancing Phase 3 ULTOMIRIS trials in NMOSD and amyotrophic lateral sclerosis (ALS), which are now over 80 percent and 50
percent enrolled, respectively.
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Dosing is underway in Phase 3 trials of ULTOMIRIS in hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA),
ALXN2060 (AG10) in ATTR cardiomyopathy in Japan, CAEL-101 in AL amyloidosis and ALXN2040 in paroxysmal nocturnal hemoglobinuria (PNH) patients with extravascular hemolysis (EVH).
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The Clinical Trial Approval (CTA) scheme for ALXN1820 (bi-specific anti-properdin mini-body) and the Investigational New Drug (IND) application
for ALXN1850 (next generation asfotase alfa) have been accepted, in Australia and the U.S., respectively, with Phase 1 studies expected to begin in the first half of 2021.
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Financial Execution Supports Strong Performance
Despite the effects of COVID-19, Alexion continued to support its commitment to disciplined financial management and strong commercial performance,
demonstrating the dedication and resilience of our colleagues around the globe. Subject to completion of the review of the financial results, the company expects to exceed the high end of 2020 full-year revenue guidance of $5.9 to $5.95 billion that
it provided in its 2020 third quarter results.
AstraZeneca and Alexion Combination
On December 12, 2020, AstraZeneca and Alexion announced that the companies entered into a definitive agreement for AstraZeneca to acquire Alexion, in which
Alexion shareholders will receive $60 in cash and 2.1243 AstraZeneca American Depositary Shares (ADSs) for each Alexion share. Based on AstraZeneca’s reference average ADR price of $54.14 at the time of the announcement, this implied total
consideration to Alexion shareholders of $39 billion or $175 per share. The acquisition has the potential to advance the shared science-led mission of both companies to leverage complementary approaches to developing life-changing medicines. The
proposed combination will broaden Alexion’s footprint, enabling the company to help more patients, pursue innovative science in new areas and expand its therapies in additional geographies. In addition, the transaction delivers significant value for
Alexion’s shareholders, who will have an important stake in the combined company’s future results. Subject to receipt of regulatory clearances and the approval by AstraZeneca and Alexion shareholders, the companies expect the acquisition to close in
the third quarter of 2021.
Presentation at the 39th Annual J.P. Morgan Healthcare Conference
Alexion will webcast its corporate presentation, given by Aradhana Sarin, M.D., Chief Financial Officer, at the 39th Annual J.P. Morgan Healthcare
Conference today, Tuesday, January 12, 2021 at 7:30 a.m. Eastern Time. Audio webcasts of the presentations will be available live at: http://ir.alexion.com. Archived versions of the remarks will also be available through the company’s website for a
limited time following the conferences.
About Alexion
Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the
discovery, development and commercialization of life-changing medicines. As a leader in rare diseases for more than 25 years, Alexion has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal
hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), as well as the first and only approved complement inhibitor to treat anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG) and neuromyelitis optica
spectrum disorder (NMOSD). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D) as well as the
first and only approved Factor Xa inhibitor reversal agent. In addition, the company is developing several mid-to-late-stage therapies, including a copper-binding agent for Wilson disease, an anti-neonatal Fc receptor (FcRn) antibody for rare
Immunoglobulin G (IgG)-mediated diseases and an oral Factor D inhibitor as well as several early-stage therapies, including one for light chain (AL) amyloidosis, a second oral Factor D inhibitor and a third complement inhibitor. Alexion focuses its
research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, metabolic disorders, cardiology and ophthalmology. Headquartered in Boston,
Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. This press release and further information about Alexion can be found at: www.alexion.com.
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Additional Information and Where to Find It
In connection with the proposed transaction, AstraZeneca PLC
(“AstraZeneca”) intends to file with the SEC a registration statement on Form F-4 that will include a proxy statement of Alexion and that also constitutes a prospectus of AstraZeneca. Each of Alexion and AstraZeneca may also file other relevant
documents with the U.S. Securities and Exchange Commission (“SEC”) regarding the proposed transaction. This document is not a substitute for the proxy statement/prospectus or registration statement or any other document that Alexion or
AstraZeneca may file with the SEC. The definitive proxy statement/prospectus (if and when available) will be mailed to stockholders of Alexion. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE REGISTRATION STATEMENT, PROXY
STATEMENT/PROSPECTUS AND ANY OTHER RELEVANT DOCUMENTS THAT MAY BE FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY IF AND WHEN THEY BECOME AVAILABLE BECAUSE THEY CONTAIN OR WILL
CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. Investors and security holders will be able to obtain free copies of the registration statement and proxy statement/prospectus (if and when available) and other documents containing
important information about Alexion, AstraZeneca and the proposed transaction, once such documents are filed with the SEC through the website maintained by the SEC at http://www.sec.gov. Copies of the documents filed with the SEC by Alexion will be available free of charge on Alexion’s website at http://www.alexion.com or by contacting Alexion’s Investor Relations Department by email at InvestorRelations@alexion.com. Copies of
the documents filed with the SEC by AstraZeneca will be available free of charge on AstraZeneca’s website at https://www.astrazeneca.com/investor-relations.html or by contacting AstraZeneca’s Investor Relations department by email at global-mediateam@astrazeneca.com.
Participants in the Solicitation
Alexion, AstraZeneca, their respective directors and certain of their executive officers and other employees may be deemed to be
participants in the solicitation of proxies from Alexion’s stockholders in connection with the proposed transaction. Information regarding the persons who may, under the rules of the SEC, be deemed participants in the solicitation of Alexion
stockholders in connection with the proposed mergers, including a description of their direct or indirect interests, by security holdings or otherwise, will be set forth in the proxy statement/prospectus when it is filed with the SEC. Information
about Alexion’s directors and executive officers is available in Alexion’s proxy statement for its 2020 annual meeting of stockholders, which was filed with the SEC on March 26, 2020, Alexion’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2019, which was filed with the SEC on February 4, 2020, and other documents subsequently filed by Alexion with the SEC. Information about AstraZeneca’s directors and executive officers is available in AstraZeneca’s Form 20-F filed
with the SEC on March 3, 2020, and other documents subsequently filed by AstraZeneca with the SEC.
No Offer or Solicitation
This communication is not intended to and shall not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any
securities, or a solicitation of any vote or approval, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any
such jurisdiction. No offering of securities shall be made, except by means of a prospectus meeting the requirements of Section 10 of the U.S. Securities Act of 1933, as amended.
Forward Looking Statements
This communication contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. You can generally identify forward-looking statements by the use of forward-looking terminology such as
“anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “explore,” “evaluate,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” or “will,” or the negative thereof or other variations thereon or
comparable terminology. These forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond Alexion’s and AstraZeneca’s control. Statements in this communication regarding
Alexion, AstraZeneca and the combined company that are forward-looking, including anticipated revenue for Alexion for fiscal year 2020, future revenue for Alexion (including in 2025), 10 potential new launches by 2023, projections as to the anticipated benefits of the proposed transaction, the impact of the proposed transaction on Alexion’s and AstraZeneca’s businesses and
future financial and operating results, the amount and timing of synergies from the proposed transaction, the terms and scope of the expected financing for the proposed transaction, the aggregate amount of indebtedness of the combined company
following the closing of the proposed transaction, are based on management’s estimates, assumptions and projections, and are subject to significant uncertainties and other factors, many of which are beyond Alexion’s and AstraZeneca’s control.
These factors include, among other things, market factors, competitive product development and approvals, pricing controls and pressures (including changes in rules and practices of managed care groups and institutional and governmental
purchasers), economic conditions such as interest rate and currency exchange rate fluctuations, judicial decisions, claims and concerns that may arise regarding the safety and efficacy of in-line products and product candidates, changes to
wholesaler inventory levels, variability in data provided by third parties, changes in, and interpretation of, governmental regulations and legislation affecting domestic or foreign operations, including tax obligations, changes to business or
tax planning strategies, difficulties and delays in product development, manufacturing or sales including any potential future recalls, patent positions and the ultimate outcome of any litigation matter. Additional information concerning these
risks, uncertainties and assumptions can be found in Alexion’s and AstraZeneca’s respective filings with the SEC, including the risk factors discussed in Alexion’s most recent Annual Report on Form 10-K, as updated by its Quarterly Reports on
Form 10-Q, in AstraZeneca’s most recent Annual Report on Form 20-F and in each company’s future filings with the SEC. Important risk factors could cause actual future results and other future events to differ materially from those currently
estimated by management, including, but not limited to, the risks that: a condition to the closing the proposed acquisition may not be satisfied; a regulatory approval that may be required for the proposed acquisition is delayed, is not obtained
or is obtained subject to conditions that are not anticipated; AstraZeneca is unable to achieve the synergies and value creation contemplated by the proposed acquisition; AstraZeneca is unable to promptly and effectively integrate Alexion’ s
businesses; management’s time and attention is diverted on transaction related issues; disruption from the transaction makes it more difficult to maintain business, contractual and operational relationships; the credit ratings of the combined
company declines following the proposed acquisition; legal proceedings are instituted against Alexion, AstraZeneca or the combined company; Alexion, AstraZeneca or the combined company is unable to retain key personnel; and the announcement or
the consummation of the proposed acquisition has a negative effect on the market price of the capital stock of Alexion or AstraZeneca or on Alexion’s or AstraZeneca’s operating results. No assurances can be given that any of the events
anticipated by the forward-looking statements will transpire or occur, or if any of them do occur, what impact they will have on the results of operations, financial condition or cash flows of Alexion or AstraZeneca. Should any risks and
uncertainties develop into actual events, these developments could have a material adverse effect on the proposed transaction and/or Alexion or AstraZeneca, AstraZeneca’s ability to successfully complete the proposed transaction and/or realize
the expected benefits from the proposed transaction. You are cautioned not to rely on Alexion’s and AstraZeneca’s forward-looking statements. These forward-looking statements are and will be based upon management’s then-current views and
assumptions regarding future events and operating performance, and are applicable only as of the dates of such statements. Neither Alexion nor AstraZeneca assumes any duty to update or revise forward-looking statements, whether as a result of
new information, future events or otherwise, as of any future date.
Alexion Contacts:
Media
Megan Goulart, 857-338-8634
Executive Director, Corporate Communications
Investors
Chris Stevo, 857-338-9309
Head of Investor Relations